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Completed

NCT Number: NCT07237854

Effect of Training Intensity on Microvascular Function

The aim of this trial is to investigate the effect of aerobic training intensity on muscle vascular function: continuous versus interval.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université Libre de Bruxelles, Faculté des Sciences de la motricité, Laboratoire de kinésithérapie

Brussels, Anderlecht, 1070, Belgium

About this study

This trial will compare the hemodynamic effects of aerobic training on muscle microvascular function between participants randomly assigned to one of two groups: a continuous training group and an high-intensity interval training group.

All data concerning the primary and secondary outcomes will be obtained at the start and repeated at the end of 8 weeks aerobic training.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female or male between 18 and 45 years
  • Be sedentary
  • Able to cycle
  • Able to provide written informed consent

Exclusion criteria

  • Have a pathology that may impact vascular function as :
  • cardiac pathology
  • pneumological pathology
  • metabolic pathology
  • Smoke

Treatment and study plan

Percutaneous muscle biopsies of the vastus lateralis (quadriceps)

Procedure

Percutaneous muscle biopsies of the vastus lateralis (quadriceps) were performed under local anesthesia. Samples were collected at baseline and/or post-intervention to assess microvascular structure, fiber composition, and molecular adaptations to aerobic training.

Measurement of the maximal oxygen uptake (VO2max)

Other

Cardiopulmonary Exercise Testing (CPET) Maximal oxygen consumption (VO₂max) was assessed using an incremental stepwise protocol on a cycle ergometer. Participants performed the test at baseline and after the 8-week training intervention. Respiratory gas exchange was continuously measured using a COSMED K5 portable metabolic system, which provided breath-by-breath analysis of oxygen uptake (VO₂), carbon dioxide production (VCO₂), and ventilation parameters. The test was terminated upon volitional exhaustion or when predefined criteria for VO₂max plateau were met.

Non-Invasive Cardiac Output Measurement (Innocor)

Other

Maximal cardiac output was assessed at peak exercise intensity during cardiopulmonary exercise testing (CPET) using the Innocor device. This system employs the inert gas rebreathing technique, which involves the controlled inhalation of a gas mixture containing nitrous oxide (N₂O) and sulfur hexafluoride (SF₆). By analyzing the washout kinetics of these gases during rebreathing, the device estimates pulmonary blood flow, which is then used to calculate cardiac output non-invasively. Measurements were performed at the maximal workload reached during the incremental cycling test.

Primary outcomes

  1. Percutaneous muscle biopsies of the vastus lateralis

    Time frame: At baseline and after completion of the 8-week intervention

    Muscle tissue samples obtained from the vastus lateralis were processed using optical clearing and immunohistochemical staining techniques to visualize the microvascular network. Confocal microscopy was employed to acquire high-resolution three-dimensional images of arterioles, capillaries, and venules. Quantitative assessments included:

    • Internal diameter measurements, based on endothelial cell boundaries (intima layer)
    • External diameter measurements, based on smooth muscle cells and pericytes (media layer)
    • Capillary density, determined by counting the number of capillaries per sample volume

Secondary outcomes

  1. Cardiopulmonary Exercise Testing (CPET)

    Time frame: At baseline and after completion of the 8-week intervention

    VO₂max was determined using a graded, incremental exercise test performed on a cycle ergometer until volitional exhaustion. Throughout the test, respiratory gases were continuously measured using a metabolic cart (e.g., COSMED K5), which provided breath-by-breath analysis.

    The following parameters were recorded :

    • VO₂ (oxygen uptake) in mL/min
    • VCO₂ (carbon dioxide production) in mL/min
    • Minute ventilation (VE) in L/min
  2. Maximal Cardiac Output Measurement Using Inert Gas Rebreathing (Innocor)

    Time frame: At baseline and after completion of the 8-week intervention

    Innocor is a medical device that estimates cardiac output using the inert gas rebreathing technique, a validated non-invasive method. During the procedure, the participant inhales a gas mixture containing nitrous oxide (N₂O) and sulfur hexafluoride (SF₆) through a closed circuit. These inert gases are absorbed and eliminated at rates proportional to pulmonary blood flow. By analyzing the washout kinetics of these gases during a brief rebreathing period, Innocor calculates pulmonary blood flow, which is then used to estimate cardiac output. This measurement is typically performed at rest or at peak exercise intensity, such as during the final stage of a cardiopulmonary exercise test (CPET).

    The system provides real-time data on:

    • Cardiac output (L/min)
    • Stroke volume (ml/min)
    • Heart rate (bpm)
    • Pulmonary blood flow (L/min)

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

Effect of Continuous Versus High-intensity Interval Aerobic Training on the Muscular Vascular Adaptation

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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